School of Nursing, Sun Yat-sen University, Guangzhou, Guangdong, China.
Department of Medicine, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
BMJ Open. 2022 Dec 30;12(12):e063814. doi: 10.1136/bmjopen-2022-063814.
Research on the needs and preferences of patients with poorly controlled type 2 diabetes mellitus (T2DM) with mobile health (mHealth) service is limited. With the principles of co-production, this study aims to address this research gap by exploring the health needs of Chinese patients with poorly controlled T2DM.
This study uses a three-phase, exploratory sequential mixed-method design. Phase 1 aims to assess the health needs of patients with poorly controlled T2DM by conducting semi-structured interviews with patients, doctors and nurses. Participants will be recruited by purposive sampling with maximum variation. Content analysis will be employed. Phase 2 will form item generation and develop the mHealth need scale. The scale will be subject to pilot testing and psychometric evaluation, including content validity, construct validity, discriminant validity, internal validity and test-retest reliability. Phase 3 will explore the priority of health needs perceived by patients with poorly controlled T2DM through a cross-sectional study. The measurement tools include an mHealth needs scale, the Summary of Diabetes Self-care Activities Questionnaire, the Diabetes Empowerment Scale-Short Form, the Diabetes Health Literacy Scale and the eHealth Literacy Scale. Multiple regression techniques with a hierarchical block design will be used for the model building to identify the factors contributing to the heterogeneity of the perceived mHealth needs. The findings of phase 1 and phase 3 will be integrated using data correlation, comparison and consolidation.
The Ethics Committee of the School of Nursing, Sun Yat-sen University, has approved this study (No. 2021ZSLYEC). The results of this study will be disseminated through conference presentations and peer-reviewed publications.
利用移动医疗（mHealth）服务研究血糖控制不佳的 2 型糖尿病（T2DM）患者的需求和偏好的研究有限。本研究遵循共同生产原则，旨在通过探索中国血糖控制不佳的 T2DM 患者的健康需求来填补这一研究空白。
本研究采用三阶段、探索性序贯混合方法设计。第 1 阶段旨在通过对患者、医生和护士进行半结构式访谈来评估血糖控制不佳的 T2DM 患者的健康需求。将采用最大变异的目的性抽样来招募参与者。将采用内容分析法。第 2 阶段将形成项目生成并开发 mHealth 需求量表。该量表将进行试点测试和心理测量评估，包括内容有效性、结构有效性、判别有效性、内部有效性和重测信度。第 3 阶段将通过横断面研究探讨血糖控制不佳的 T2DM 患者感知的健康需求的优先级。测量工具包括 mHealth 需求量表、糖尿病自我护理活动综述问卷、糖尿病授权量表-简化版、糖尿病健康素养量表和电子健康素养量表。采用带有分层块设计的多元回归技术建立模型，以确定导致感知的 mHealth 需求异质性的因素。将使用数据相关、比较和整合的方法将第 1 阶段和第 3 阶段的研究结果整合起来。
中山大学护理学院伦理委员会已批准本研究（编号 2021ZSLYEC）。本研究的结果将通过会议报告和同行评审出版物进行传播。
